Global HLA Typing for Transplant Market Size, Forecast, and Trend Highlights Over 2025-2037
HLA Typing for Transplant Market size was valued at USD 1.4 billion in 2024 and is projected to reach USD 3.8 billion by the end of 2037, rising at a CAGR of 8.1% during the forecast period, i.e., 2025-2037. In 2025, the industry size of HLA typing for transplant is estimated at USD 1.6 billion.
The global HLA typing for transplant market is expanding at a rapid pace due to its large consumer base being affected by end-stage renal disease, leukemia, and solid organ failures. According to the WHO report published in 2024, the patient pool requiring HLA typing for transplants reached approximately 1.1 million cases in a year, reflecting the increased demand. Besides, the supply chain of these reagents relies on several raw materials such as DNA polymerases, fluorescent probes, and microarrays, which are currently being imported from the U.S., Germany, and Japan, further contributing to wider market upliftment.
Governments across the nations are initiating funding towards the market upliftment for research activities that bring innovation in the field. In this regard, the EU’s Horizon Europe program assigned €160 million for portable HLA typing systems, aiming to streamline transplant logistics. Furthermore, the global trade in the market is positively impacting industrial expansion internationally by reaching USD 860 million in 2024, with the U.S. and Germany leading exports, and the developing nations India and China dominate the imports, thereby drawing the interest of key leaders to invest in this sector.
HLA Typing for Transplant Sector: Growth Drivers and Challenges
Growth Drivers
- Rising volumes of organ transplantations: There is a surge in the number of individuals opting for organ transplantation, which will lead to a surge in the demand for HLA typing for transplant market. As per a WHO report published in 2024, the number of organ transplant procedures reached more than 140,000 in a year. Besides the developing countries such as India and Brazil are expanding their transplant infrastructure, thereby increasing the necessity for HLA testing, denoting a positive market outlook.
- Diagnostic advancements: The ongoing proceedings in precision diagnostics significantly drive business in the HLA typing for transplant market. NIH in 2023 reported that next-generation sequencing and PCR-based HLA typing are capturing above 62% of the market share, appreciably lowering graft rejection rates by 35%. Besides the U.S. FDA, it fast-tracked five new HLA assays, reflecting the growing adoption. Additionally, a clinical study by AHRQ in 2022 found that NGS-based typing saves hospital stays by 20%, saving $500 million annually in monitoring after transplantation, thus uplifting market expansion.
Historical Patient Growth and Its Impact on HLA Typing for Transplant Market Expansion
The global HLA typing for transplant market is gaining traction, owing to its large patient pool. Moreover, there is a fast-rising prevalence of renal disease, hematologic cancers, and solid organ failures across all nations. This high consumer base directly correlates with today’s growing industry as transplant centers necessitate higher precise and matching solutions. Furthermore, it is reported that countries with aging populations, such as Japan and Germany, saw accelerated demand for kidney and bone marrow transplants, similarly, India and China witnessed growth due to rising ESRD cases.
The data below highlights country-specific patient growth from 2010 to 2020:
|
Country |
2010 Patients (Million) |
2020 Patients (Million) |
CAGR (2010-2020) |
|
USA |
0.87 |
1.44 |
5.4% |
|
Germany |
0.34 |
0.60 |
6.3% |
|
France |
0.30 |
0.50 |
6.0% |
|
Spain |
0.23 |
0.40 |
6.2% |
|
Australia |
0.14 |
0.26 |
7.4% |
|
Japan |
0.47 |
0.74 |
5.0% |
|
India |
0.20 |
0.69 |
14.2% |
|
China |
0.52 |
1.27 |
9.8% |
Feasible Expansion Models Shaping the Future of HLA Typing for Transplant Market
The global HLA typing for transplant market is gaining immense exposure, shaped by numerous tactical expansion models. Key trends opted by the global players to enhance their ecosystem include domestic collaborations, automation scaling, and AI-based accurate diagnostics. In this regard WHO in 2024 reported that suppliers based in India collaborated with domestic healthcare facilities and witnessed a substantial increase in revenue by 14% from 2022 to 2024, opting for affordable costs. Besides, the developed nations, such as the U.S. and the EU, are adopting subscription-based allele databases, with NIH declaring a $95 million annual revenue growth. Therefore, these expansion models are anticipated to boost the market growth.
Feasibility Models for HLA Typing Market Expansion
|
Model |
Region |
Revenue Impact |
Key Stat |
|
Public-Private Labs |
India |
+14% (2022-2024) |
Cost per test reduced by 30% |
|
NGS Automation |
USA/Germany |
$625M by 2027 |
65% of labs now use automated NGS |
|
Portable HLA Kits |
Brazil |
$130M by 2032 |
Rural access improved by 40% |
|
Allele Subscriptions |
Global |
$95M/year |
120+ transplant centers subscribed |
Challenge
- High costs of advanced equipment: One of the restricting factors in the HLA typing for transplant market is the high costs associated with this advanced equipment. In this regard, MoHFW in 2024 reported that in developing nations such as India, patients undergoing transplantation are paying more than USD 1,000 for HLA typing, which restricts the adoption among people from price-sensitive regions. Besides, in Brazil, SUS covers only 35% of tests, reflecting the healthcare disparities. Therefore, these expenses mark a considerable hurdle in the market, restricting optimum consumer base adoption.
HLA Typing for Transplant Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
8.1% |
|
Base Year Market Size (2024) |
USD 1.4 billion |
|
Forecast Year Market Size (2037) |
USD 3.8 billion |
|
Regional Scope |
|
HLA Typing for Transplant Segmentation
Technology (Molecular Assay Technologies, Serological Assays)
Based on technology, the molecular assay technology segment is expected to garner the highest share of 87.2% in the HLA typing for transplant market by the end of 2037. The dominance of the segment is attributable to their high procedural efficacy, reduced turnaround times, and their enhanced ability to analyze multiple samples at the same time. Moreover, these technologies offer high-resolution typing, which is highly essential for matching donors and recipients more accurately, reducing the risk of graft rejection. Besides the advantages offered by them make them a preferred choice for HLA typing in transplant diagnostics, thereby accelerating the segment’s dominance.
Application (Diagnostic, Research)
Based on application, the diagnostics segment is projected to account for a lucrative share of 70.3% in the HLA typing for transplant market during the forecast period. The segment benefits from increasing demand for accurate and timely interventions in HLA typing transplant procedures. Besides the ongoing advancements in molecular assays and the increasing instances of transplant surgeries across all nations, this drives business in the field, further contributing to the segment’s growth.
Our in-depth analysis of the HLA typing for transplant market includes the following segments:
|
Technology |
|
|
Application |
|
|
End User |
|
Vishnu Nair
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HLA Typing for Transplant Industry - Regional Synopsis
North America Market Analysis
The North America HLA typing for transplant market is poised to capture the largest share of 47.5% during the forecast period, 2025-2037. The region benefits from an advanced healthcare infrastructure and a high volume of organ transplant procedures that significantly contribute to the HLA typing. In this regard, the Centers for Disease Control and Prevention states that nearly 90,000 people in the U.S. are affected by sickle cell disease, which reflects the need for accurate HLA matching in treatment procedures. Besides, CMS notified that it expanded reimbursement policies to cover a wide range of HLA typing services, fostering increased access to patients, thereby augmenting industry expansion.
There is a huge opportunity for market in Canada due to its robust medical infrastructure and a growing demand for organ transplants. Besides, there is an exceptional support from the country’s government, due to which Health Canada assigned a significant portion of its federal healthcare budget towards the transplant-associated treatments. Similarly, provincial health ministries in Ontario and Columbia also extended their support with increased investments in HLA typing technologies, aiming to enhance the accuracy. Hence, these factors readily blister the market progression in the region.
APAC Market Statistics
Asia Pacific’s HLA typing for transplant market is anticipated to grow at the fastest rate during the forecast timeline, owing to the increasing medical expenditure, awareness about organ donation, and advancements in molecular diagnostics. The increasing burden of chronic diseases and innovations such as next-generation sequencing and polymerase chain reaction enhance the accuracy and efficiency of HLA typing, resulting in positive patient outcomes. This further led to a projection of the market to reach USD 172.6 million in the next few years, with expanded access to HLA typing across the region.
India’s market is unfolding remarkable growth opportunities, which are expected to reach USD 59.9 million by 2030, rising at a CAGR of 11.8%. Besides, it is noted that the country’s government offers its extended support through the establishment of the DATRI Blood Stem Cell Donors Registry, which led to expanded access to HLA typing services in India. Additionally, this resulted in more than 1,200 successful transplants, highlighting the critical role of HLA compatibility in bringing positive outcomes, further accelerating the adoption of HLA typing in the transplant market by 2037.
Companies Dominating the HLA Typing for Transplant Landscape
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
There is an intensifying competition between the companies involved in the HLA typing for transplant market, with numerous strategies implemented to strengthen their global ecosystem. The market landscape is mainly dominated by key players in the U.S. and Europe, with a maximum revenue share of 78%, leveraging NGS automation and AI-based technologies. Besides, countries such as Thermo Fisher and Illumina are leading the market with high-precision sequencing. Hence, these constant efforts from major firms are dramatically influencing industry expansion. Here is a list of key players operating in the global market:
|
Company Name |
Country |
Market Share |
|
Thermo Fisher Scientific |
USA |
24% |
|
Illumina |
USA |
20% |
|
QIAGEN |
Germany |
14% |
|
Bio-Rad Laboratories |
USA |
10% |
|
Roche Diagnostics |
Switzerland |
9% |
|
Immucor (Werfen) |
Spain |
xx% |
|
Becton Dickinson (BD) |
USA |
xx% |
|
Luminex (DiaSorin) |
Italy |
xx% |
|
Takara Bio |
Japan |
xx% |
|
CareDx |
USA |
xx% |
|
Omixon |
Hungary |
xx% |
|
GenDx |
Netherlands |
xx% |
|
Abbott Laboratories |
USA |
xx% |
|
Sysmex |
Japan |
xx% |
|
SeCore (Life Technologies) |
USA |
xx% |
|
Histogenetics |
USA |
xx% |
|
Cytologics |
South Korea |
xx% |
|
TBG Diagnostics |
Australia |
xx% |
|
XCyton Diagnostics |
India |
xx% |
|
Inno-Train Diagnostics |
Malaysia |
xx% |
Below are the areas covered for each company under the top 15 global manufacturers:
Recent Developments
- In August 2024, Thermo Fisher Scientific received FDA 510(k) clearance for its SeCore CDx HLA a sequencing system as a companion diagnostic for TECELRA (afamitresgene autoleucel), a T-cell receptor therapy for unresectable or metastatic synovial sarcoma.
- In January 2024, CareDx expanded its AlloSeq HCT product line with a new assay designed for high-resolution HLA typing in bone marrow and stem cell transplants. The test reduces turnaround time to 48 hours, compared to the industry standard of 5 to 7 days.
- Report ID: 2629
- Published Date: Jun 02, 2025
- Report Format: PDF, PPT
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